Pre-Market Programs:
- New Product Development: Design Control & Validations
- Regulatory Filing: 510K in USA and International: CE, CFDA, PMDA, MFDS, ANVIZA, CMDCAS and others
Post-Market Programs:
- Compliance (Remediations on 483s, Warning Letter & Consent Decree)
- QMS and Processes Integration(CAPA, Complaints, GMP, Change Control & Supplier Mgmt.)
- Information Systems Enhancement (SAP, Agile, Oracle)
Corporate Training & Solutions Package:
- Lean Six Sigma (Basic or fundamental way to run the business efficiently)
- Business Excellence (Overall company business strategy, processes and executions)
- DMAIC (Operational Excellence) for Existing Product, Process and Service
- DFSS (Design for Six Sigma) for New Product, New Process and New Service
- Kaizen (Quick Blitz Continuous Improvement)